Kornimate/medical-research-clean huggingface dataset:
safer parenteral nutrition in pediatric short bowel syndrome to decrease liver damage

Conditions: Cholestasis of Parenteral Nutrition

Summary: to provide children dependent on total parenteral nutrition with omegaven®, a fish oil-based intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable oil-based intravenous lipid emulsions, and that may therefore reduce the need for liver transplantation.


Eligibility criteria:
inclusion criteria: * the targeted population for enrollment is the cohort of patients with tpn-dependent short bowel syndrome, defined as any pediatric patient who, following abdominal surgery, has a residual small bowel length less than 25% of that predicted for gestational age or requires postoperative tpn for more than 42 days because of gastrointestinal intolerance and who has developed tpn-associated liver disease sufficient to pose a significant risk for progression to liver failure based on the following criteria: * total serum bilirubin concentration greater than 3 mg/dl after a total duration of tpn greater than 2 months in the absence of a proven episode of bacteremia within the preceding 3 weeks. plus either: • platelet count less than 200,000/μl after a total duration of tpn greater than 2 months in the absence of a proven episode of bacteremia within the preceding 3 weeks. or • serum albumin concentration less than 3.2 mg/dl after a total duration of tpn greater than 2 months in the absence of a proven episode of bacteremia within the preceding 3 weeks. patients with coagulopathy due to parenteral nutrition-associated liver disease (inr \> 1.2) will be potential candidates for enrollment, because patients with an elevated inr exceeding 2 have demonstrated resolution of coagulopathy after treatment with omegaven®. similarly, patients with hyperlipidemia will be potential candidates for enrollment. alternatively, patients currently receiving omegaven that was initiated at another center because of intestinal failure with liver disease that do not need to meet the lab criteria listed above. the subject may continue omegaven under this protocol at the discretion of the principle investigator. exclusion criteria: patients with a history of the following will be excluded from enrollment in this protocol: * allergy to fish or egg protein. * liver disease proven or suspected to be caused by a process other than tpn-dependent short bowel syndrome, including but not limited to hepatitis c, hepatitis b, cystic fibrosis, biliary atresia, alagille syndrome, familial intrahepatic cholestasis, and alpha-1-antitrypsin deficiency. * refusal of third party providers to reimburse hospital for the cost of omegaven®.

Keywords: total parenteral nutrition tpn intestinal failure short bowel syndrome cholestasis intestinal failure associated liver disease parenteral nutrition associated liver disease
medical education for sepsis source control and antibiotics

Conditions: Sepsis; Shock, Septic

Summary: patients with severe sepsis or septic shock suffer from life-threatening infections. fast and adequate therapy with antibiotics is crucial for survival. current guidelines recommend the application of broad-spectrum antibiotics within 1 hour after diagnosis. however, recent studies showed that such treatment is delayed for several hours. in this study, medical staff of participating hospitals is trained to achieve a duration until antimicrobial therapy of less than 1 hour. tools of change management are used. the data are compared to a control group (hospitals without intervention). it is hypothesized that a multifaceted educational program decreases duration until antimicrobial therapy and improves survival.

this study is a cluster randomized trial (crt) where the hospitals are the clusters. 44 hospitals in germany have confirmed their participation. hospitals are randomized into two groups: a control and an interventional group. the control group receives conventional cmes. the interventional group receives tools for increasing awareness such as posters and brochures. quality measure such as benchmarking and feedback of quality indicators are used. depending on the improvement process tools such as swot analyses and resistance radar will be implemented. the crt was preceded by a 5 months observational study (dec. 2010 - april 2011). in about 1000 patients, participating hospitals documented their patients with severe sepsis or septic shock into a register. these data are used for final sample size calculation of the crt and for stratification of the randomization. the groups switch after completion of the crt and observation continues. thus, centers of the control group now receive the change management while the former intervention group is now without external support and is assessed for sustainability of the intervention. this study phase is planned for nov. 2013 until march 2015. sample size will be calculated when the crt has been finished.

Eligibility criteria:
inclusion criteria: 1. for the hospitals (cluster): * involved in the primary care of patients with severe sepsis/septic shock * willing to participate in a guideline implementation process 2. for the patients: * new onset of suspicion of severe sepsis or septic shock in the following settings: 1. prehospital 2. emergency department 3. operating theatre 4. regular ward 5. intensive care unit (icu)/intermediate care unit (imc) exclusion criteria: 1. for the hospitals (cluster): * no intensive care unit available * no acute care for patients with severe sepsis and septic shock 2. for the patients: * start of sepsis therapy in a non-study site * patients not admitted to the icu/imc * no commitment to full medical support (i.e. dnr)

Keywords: sepsis shock, septic quality assurance, health care quality control survival rate follow-up studies anti-infective agents/*therapeutic use
efficacy and safety of remimazolam tosylate for sedation in gastroscopy

Conditions: Hypoxia; Gastric Cancer; Sedation Complication; Propofol Adverse Reaction

Summary: propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. therefore, the incidence of intraoperative hypoxemia and hypotension is high. remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. these advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.


Eligibility criteria:
inclusion criteria: - 1)18≤age≤60 years old, no gender limit; 2) patients receiving routine gastroscopy diagnosis and treatment; 3) asa score is i or ii; 4) 18 kg/m2\<bmi\<28kg/m2； 5) it is estimated that the operation time of gastroscope will not exceed 30 minutes; 6) clearly understand, voluntarily participate in the research, and be signed and informed consent. exclusion criteria: 1. need to perform complicated endoscopic diagnosis and treatment techniques (such as cholangiopancreatography surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa stripping, oral endoscopic muscle dissection, etc.); 2. patients who intend to undergo tracheal intubation; 3. it is judged to be difficult to manage the respiratory tract (modified mallampati score is iv)patient; 4. anemia or thrombocytopenia,( hb\<90g/l, plt\<80×109/l); 5. diagnosed lung diseases (asthma, bronchitis, copd, pulmonary bullae,pulmonary embolism, pulmonary edema, lung cancer); 6. liver and kidney disease;( ast and/or alt≥2.5×uln,tbil≥1.5×uln, blood creatinine is greater than the upper limit of normal); 7. there is a history of drug and/or alcohol abuse within 2 years before the beginning of the screening period.the average daily alcohol consumption exceeds 2 units of alcohol (1 unit = 360 ml beer liquor or 45 ml liquor with 40% alcohol content or 150 ml grapes liqueur); 8. hypertensive patients whose blood pressure has not been satisfactorily controlled by antihypertensive drugs(sitting systolic blood pressure ≥160 mmhg during screening period, and/or diastolic pressure during screening period pressure ≥100 mmhg); 9. sitting systolic blood pressure ≤90 mmhg during the screening period; 10. women who are pregnant or breastfeeding; 11. benzodiazepines, opioids, propofol, lidoca those who are allergic or contraindicated due to their drug components; 12. participated in other drug clinical trials as subjects in the past 3 months; 13. the investigator believes that it is not appropriate to participate in this trial; 14. a well-diagnosed heart disease (heart failure, angina pectoris, myocardial infarction, heart rhythmabnormalities etc.).

Keywords: hypoxia efficacy and safety gastroscope remimazolam propofol
optimal settings of non invasive respiratory support in preterm newborns

Conditions: Preterm Infant; Respiratory Distress Syndrome

Summary: noninvasive respiratory supports (nrs), such as continuous positive airway pressure (cpap), noninvasive ventilation, high flow nasal cannula (hfnc) or nasal oxygen (o2), are commonly used in preterm newborns hospitalized in neonatal intensive care unit. however, given the lack of validated criteria, clinicians usually choose the nrs according to clinical parameters and patients' comfort. several studies have demonstrated the interest of the measurement of the work of breathing (wob) to optimize the settings of nrs in children, but no study has already demonstrated the utility of wob to optimize the settings of nrs in preterm infants. therefore, the aim of this study is to measure the wob during the utilisation of three different nrs (cpap, hfnc, o2), in order to optimize the choice of the type and settings of nrs in a randomized group of 30 newborns born prematurely before 30 gestational weeks and still requiring nrs at 29 post conceptual weeks. moreover, the investigators will compare in the newborns with the optimized nrs by wob vs. a standard care control group (nrs type and settings determined as clinical routine): 1) the respiratory morbidity and mortality one month after the initial assessment, and at the time of hospital discharge (or transfer) or at 36 weeks of age corrected (whatever comes first), 2) the weaning time of the nrs, 3) the incidence and severity of broncho-pulmonary dysplasia (bpd) at 36 weeks of age corrected. indeed, incidence of bpd is still around 40% in premature infants born before 28 gestational weeks. the hypothesis of the investigators' study is that the optimization of the type and settings of the nrs could reduce the weaning delay and contribute to reduce the incidence and severity of bpd in premature newborns.


Eligibility criteria:
inclusion criteria: * preterm infants born between 23 and 30 ga * aged over 29 weeks of corrected age at the time of assessment and needing a non invasive respiratory support since at least 4 weeks of age exclusion criteria: * hemodynamic and/or neurologic instability * invasive ventilation * congenital cardiopathy and/or significant patent ductus arteriosus * sedation * congenital pulmonary disease and/or other malformations
rehabilitating (stroke-induced) apraxia with direct current stimulation

Conditions: Stroke; Apraxia

Summary: the objective of the clinical trial is to investigate whether weak transcranial direct current stimulation (tdcs) can ameliorate the motor cognitive deficit apraxia during stroke rehabilitation. stroke patients with apraxia will either receive a real stimulation or a sham stimulation (placebo) for 10 minutes at a time on 5 consecutive days during their in-patient stay in a rehabilitation center. additionally, motor tasks are performed before and after the stimulation. the effect of the weak current stimulation on motor function is assessed 3-4 days after the last stimulation and 3 months after enrollment.

despite the high incidence of the motor cognitive deficit apraxia after left-hemispheric stroke, evidence-based therapies do not exist. this randomized controlled clinical trial (rct) investigates whether anodal transcranial direct current stimulation (tdcs) as an add-on therapy during neuro-rehabilitation can ameliorate apraxic deficits in patients with left hemisphere stroke. therefore, anodal tdcs is applied over the parietal cortex of the left, lesioned hemisphere with an intensity of 2 ma for 10 minutes at a time on 5 consecutive days in combination with motor tasks before and after the stimulation. the effect of the stimulation is compared to a sham stimulation. moreover, application of a pre-programmed study mode ensures a double-blind study design (patient and investigator). the performance in the apraxia test kas (cologne apraxia screening) 3-4 days after the last stimulation, compared to baseline, serves as primary endpoint of the study. secondary endpoints are evaluated using various apraxia tests, motor tests and neuropsychological tests 3-4 days after the last stimulation and 3 months after enrollment.

Eligibility criteria:
inclusion criteria: * left hemispheric ischemic stroke in the subacute/ chronic phase (\>10 days and \<180 days post-stroke) * clinical confirmation of apraxia by kas (cologne apraxia screening), cut-off ≤ 76/ 80 points; * age 18 - 90 years; * written informed consent exclusion criteria: * pregnancy, breastfeeding and women without exclusion of pregnancy * patients with clinical manifestation of a stroke prior to the index-stroke * malignant disease with affection of central nervous system * life expectancy \<12 months * current addiction to alcohol or drugs or other addictive disease (exception: nicotine) * current clinically manifest psychiatric disorders, such as schizophrenia or severe depressive episode * epileptic seizure within the past two years * continuous medication during the intervention phase with benzodiazepine, antipsychotics of high potential and anti-epileptic drugs taken for prophylaxis of epileptic seizures * enrollment in other studies with brain stimulation in the time period after the index stroke * heart pacemaker * electrodes for deep brain stimulation or other metal implants in the head (expected are dental fillings and inlays) * craniectomy or trepanation * vulnerable skin lesions at electrode positions * poor motivation/ cooperation

Keywords: tdcs
evaluation of tongue base mucosectomy & step serial sectioning

Conditions: Squamous Cell Carcinoma of the Oropharynx

Summary: squamous cell carcinoma (scc) is a cancer that originates from the cells lining the body and can spread into the lymph glands and beyond. some patients first present with an scc which has moved to the lymph glands of the neck. clinical examination and imaging investigations are performed to try and identify the site where the cancer has originated. however, if no original site can be identified, then the investigators call these 'cancers of an unknown primary' (cup) of the head and neck. one region where these cancers could have originated from is the oropharynx. there are two areas in the oropharynx were cancers commonly arise. one area is the palatine tonsils, which can be removed for analysis with an operation called tonsillectomy. the other area is the tissue lining the back of the tongue, known as the tongue base. a relatively new surgical technique called 'tongue base mucosectomy' (tbm) allows removal of this tissue to see if the primary cancer is contained within it. this study will then use a histological method called 'step serial sectioning' (sss) to look in more detail at the tonsils and tongue base, hoping to increase the detection rate of the primary cancer. centres performing tbm will be asked to participate. patients will be asked to consent to their tissue being used for sss after it has undergone conventional histology. anonymised samples will be sent to a central laboratory in newcastle for processing. other anonymised data regarding the patients' diagnosis and care will be collated. patients will be asked to complete questionnaires regarding pain and swallowing recovery following surgery. a smaller cohort of patients will also be interviewed as part of a qualitative research process to establish their views on cup and the acceptability of the above treatment.


Eligibility criteria:
inclusion criteria: * aged 16 or over * both sexes * cervical metastatic scc, confirmed with cytology or biopsy, undergoing tbm for identification of primary site exclusion criteria: * primary site identified by any means prior to being indicated for tbm * patients undergoing targeted biopsies or resections * patients known to have a history of previous h\&n cancers * patients known to have undergone previous radiation to the h\&n region
comparative study between vaginal progesterone alone or combined with aspirin in prevention of recurrent preterm birth

Conditions: Preterm Birth

Summary: this is a double blinded randomized placebo controlled clinical trial to detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent ptb.

the included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1), or vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).

Eligibility criteria:
inclusion criteria: 1. women of any age 2. any parity 3. healthy singleton pregnancy 4. history suggestive of one or more previous ptb 5. current pregnancy (16-20) weeks gestation. exclusion criteria: 1. multifetal pregnancy. 2. history of ante partum prom. 3. cervical incompetence or current cervical cerclage. 4. known fetal anomaly. 5. hypertension requiring medications. 6. history of thrombo-embolic disorders. 7. known allergy to progesterone or asprin. 8. known liver disease. 9. established preterm labor 10. short cervix
pediatric epilepsy study

Conditions: Epilepsy; Epilepsies, Partial

Summary: this study will evaluate the safety and effectiveness of oxcarbazepine (trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.


Eligibility criteria:
inclusion criteria: to enter this study, patients must: * have a diagnosis of partial seizures * be willing to be hospitalized * weigh a minimum of 6.6 pounds * be taking a stable dose of one to two concomitant anti-epileptic medications * have had a previous cat scan/mri confirming the absence of space occupying lesions or progressive neurological disease * have normal laboratory results exclusion criteria: to enter this study, a patient must not have or be: * seizures caused by metabolic disturbance, toxic exposure, or active infection * a primary diagnosis of generalized epilepsy (exception - secondarily generalized seizures) * a history of status epilepticus within 30 days * seizures not related to epilepsy * frequent use of additional anti-epileptic medications to treat increases in seizures (for example: rectal diazepam) * taking felbamate within 6 months * serum sodium levels \<135 meq/l * significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder requiring treatment/therapy * a history of chronic infection (e.g., hepatitis or hiv) * significant electrocardiogram (ecg) abnormalities * a nursing mother taking anti-convulsant drugs * previously demonstrated sensitivity/allergic reaction to trileptal or related compounds * used experimental medication within 30 days of entering this study

Keywords: partial seizures
rickettsial genesis to sarcoidosis in denmark

Conditions: Sarcoidosis; Rickettsia Infections

Summary: one study has suggested a connection between an infection with rickettsia species and sarcoidosis finding molecular evidence of rickettsial deoxyribonucleic acid (dna) in two patients. another study found no antibodies in twenty swedish patients with sarcoidosis. this study will further enhance the subject by three different approaches in danish patients. the purpose of this study is to find serological and molecular evidence of an infection with rickettsia species in danish patients with sarcoidosis.

the study has three approaches to the subject: 1. a serological survey of rickettsial immunoglobin g (igg)-antibodies in 50 patients with sarcoidosis compared to 50 blood donors without sarcoidosis. 2. an archival study using pre-existing lymph node biopsies, where immunohistochemical analysis, fluorescent in situ hybridization, and polymerase chain reaction will be applied to samples from 50 patients with sarcoidosis and compared to 50 patients without sarcoidosis and 10 patients with tuberculosis. 3. a prospective study using bronchoscopically obtained samples from 20 patients with sarcoidosis, compared to 20 patients without sarcoidosis. the study applies the same techniques as the second study, but enhancing the information from the patients.

Eligibility criteria:
inclusion criteria: * referred to fiberoptic bronchoscopy in the department either because of sarcoidosis, hemoptysis, chronic cough, or cancer suspicion exclusion criteria: * pregnant patients * patients under the age of 18 * patients without consent * patients with a registered wish of not having their samples used for research

Keywords: sarcoidosis rickettsia serological reactions polymerase chain reaction
the effects of inhaled aclidinium bromide/formoterol fumarate on inspiratory pleural pressures in smokers

Conditions: Smoking

Summary: this short-term study aims to prove the potential cardio-protective physiological effect of inhaled aclidinium bromide/formoterol fumarate on inspiratory pleural pressures. smoking is associated with gas-trapping (hyperinflation), even in the absence of chronic obstructive pulmonary disease. breathing in the presence of gas-trapping requires large negative inspiratory pleural pressures, which are transmitted to the surface of the heart and increase cardiac wall stress. inhaled aclidinium bromide and formoterol fumarate has been shown to reduce gas-trapping, but the impact on inspiratory pleural pressures and biomarkers of cardiac stress in smokers is unknown.


Eligibility criteria:
inclusion criteria: * current and former smokers with ≥20 pack-years of smoking history * gas-trapping (residual volume \>110% predicted) exclusion criteria: physician-diagnosis of chronic obstructive pulmonary disease in the past 1 year and regular use of long-acting antimuscarinic (lama) and/or long-acting beta-agonist (laba) (i.e., at least 30 consecutive days) * physician-diagnosis of asthma in the past 5 years * regular inhaled corticosteroid (ics) use in the past 5 years (i.e., at least 30 consecutive days) * physician-diagnosis of other lung diseases (sarcoidosis, tuberculosis, cystic fibrosis, pulmonary fibrosis, lung cancer), or long-term oxygen therapy * respiratory tract infection within 4-weeks * physician-diagnosis of arrhythmia, or significant valvular disease. * physician-diagnosis of myocardial infarction, unstable angina or heart failure requiring unscheduled outpatient or emergency department visit within 6-months. * arrhythmia or prolonged corrected qt (qtc) on electrocardiogram. * inability to use study inhaler * glaucoma * benign prostatic hypertrophy * pregnancy * allergy to the study treatment, salbutamol, lidocaine, or severe milk protein allergy (note: lactose intolerance is not an exclusion criteria) * contraindications to anti-cholinergic, beta-agonist, or cardiopulmonary exercise testing with manometry * inability to provide written informed consent